💊 Drugs Class I - Dangerous
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
All Recalls
92,900 total recalls in our database
Dynashield Skin Protectant, Net Wt. 16 oz (453.6 g), Manufactured for: Dyrnarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962, USA, Made in India, NDC 67777-407-04.
Blossom Pharmaceuticals
💊 Drugs Class I - Dangerous
cGMP deviations
Wecare Enema, 4.5 Fl Oz/133mL, Manufactured for: Dynarex Corporation, 11 Dynarex Corporation, MIddletown, NY 10941 USA, Made in India, NDC 67777-402-01.
Blossom Pharmaceuticals
💊 Drugs Class I - Dangerous
cGMP deviations
Wecare Calasoothe, Net wt. 4 oz (113 g), Manufactured for: Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962, NDC 67777-234-04.
Blossom Pharmaceuticals
💊 Drugs Class I - Dangerous
cGMP deviations
💊 Drugs Class I - Dangerous
CGMP Deviations; presence of N-nitroso-duloxetine impurity above the FDA recommended limit
Dynashield, 4 oz cream (113 g), Manufactured for: Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10852, USA, Made in India, NDC 67777-407-03.
Blossom Pharmaceuticals
💊 Drugs Class I - Dangerous
cGMP deviations
💊 Drugs Class I - Dangerous
Defective Container - A defect in the side-seal which allows leakage of product.
Nivagen, Zinc Oxide Ointment USP, Zinc Oxide 20 %, Net Wt. 1 oz. (28.4g), Nivagen Pharmaceuticals, Inc., Sacramento, CA 95827, USA, Made in India, NDC 75834-170-02.
Blossom Pharmaceuticals
💊 Drugs Class I - Dangerous
cGMP deviations
💊 Drugs Class I - Dangerous
Failed Stability Specifications: Observed OOS results: eg results for colour index
Globe Clotrimazole Cream, USP, 1 %, Net Wt. 1 oz (28.4g), Distributed by: Trifecta Pharmaceuticals USA, 101 NE Third Avenue, Suite 1500, Ft. Lauderdale, FL 33301 USA, Made in India, NDC 69396-087-01.
Blossom Pharmaceuticals
💊 Drugs Class I - Dangerous
cGMP deviations
Lanashield Skin Barrier, 4 oz. (113 g), Manfuactured for: Dynarex Corporation, 10 Gleshaw Street, Orangeburg, NY 10962 USA, Made in India, UPC 616784126319.
Blossom Pharmaceuticals
💊 Drugs Class I - Dangerous
cGMP deviations
Nivagen, Zinc Oxide Ointment, Net Wt. 1 oz. (28.4g), Nivagen Pharmaceuticals, Inc., Sacramento, CA 95827, USA Made in India, NDC 75834-170-01.
Blossom Pharmaceuticals
💊 Drugs Class I - Dangerous
cGMP deviations
Globe Clotrimazole Cream USP, 1 % Antifungal Cream, Net Wt., 5 oz. (142 g, Distributed by: Trifecta Pharmaceuticals USA, 101 NE Third Avenue, Suite 1500, Ft. Lauderdale, FL 33301, USA, NDC 69396-087-55.
Blossom Pharmaceuticals
💊 Drugs Class I - Dangerous
cGMP deviations
Dynagel, Moisturizing Wound Hydrogel, Net Wt. 3oz (84.7 g), Manufactured for: Dynarex Corporation, 16 Glenshaw Street, Orangeburg, NY 10962, UPC 61784128016.
Blossom Pharmaceuticals
💊 Drugs Class I - Dangerous
cGMP deviations
WeCare, Zinc Oxide Ointment, Net Wt. 15 oz/425 g, Manuactured for: Dynarex Corporation, 11 Dynarex Drive, Middletown, NY 10941, Made in India, NDC 67777-223-05.
Blossom Pharmaceuticals
💊 Drugs Class I - Dangerous
cGMP deviations
IntelliVue MP90. Product Number: M8010A.
Philips North America
🏥 Medical Devices Class I - Dangerous
Potential issue where the IntelliVue monitors did not alarm.
Food Intolerance Test Small
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🏥 Medical Devices Class I - Dangerous
Distribution without premarket approval/clearance.
IntelliVue MP30. Product Number: M8002A.
Philips North America
🏥 Medical Devices Class I - Dangerous
Potential issue where the IntelliVue monitors did not alarm.
Vitamin D-Test
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🏥 Medical Devices Class I - Dangerous
Distribution without premarket approval/clearance.
Candida Test
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🏥 Medical Devices Class I - Dangerous
Distribution without premarket approval/clearance.